New European Warnings and Restrictions on Painkiller Piroxicam (FELDENE): FDA Fails to Issue New Warning

We continue to classify this as a Do Not Use drug.

The European Medicines Agency (EMEA), whose decisions affect people in the 27 European Union member countries, has recently announced severe restrictions on the uniquely dangerous but widely and increasingly prescribed arthritis/painkiller drug piroxicam (FELDENE). The agency, which is the European equivalent of the Food and Drug Administration (FDA), cites “the risk of gastrointestinal side effects and serious skin reactions” as the reason for the new regulation. The European restrictions state that piroxicam should “no longer be used for treatment of short-term painful and inflammatory conditions.” The agency further warned that piroxicam should not be the first choice for “symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis [a form of arthritis that particularly affects the spine].”

The FDA has failed to issue any similar warnings for piroxicam. In addition, the FDA-approved professional and patient labeling (MedGuide) for the drug fail to point out the increased gastrointestinal toxicity seen with piroxcam compared with all other non-steroidal anti-inflammatory drugs (NSAIDs) marketed in the U.S. Contrary to the EMEA warning against short-term use, the FDA-approved MedGuide actually promotes such use by stating that piroxicam (and all other NSAIDs) are used to treat “menstrual cramps and other types of short-term pain.”

In 1994, the Health Research Group of Public Citizen petitioned the FDA to ban piroxicam because of its unique gastrointestinal toxicity and the absence of any evidence of a unique benefit. In a series of studies involving patients in many different countries, it was found that, in comparison to ibuprofen (ADVIL, MOTRIN), piroxicam was between 2.8 and 7.1 times more likely to be associated with severe gastrointestinal toxicity, defined as bleeding, ulceration or perforation. No other NSAID was as consistently as high in gastrointestinal risk as piroxicam.

In addition, there were then, through mid-1994, 144 reports to the FDA of deaths in patients from serious gastrointestinal side effects, almost 90 percent of which were in patients over the age of 60.

The petition was turned down and, as of now, all NSAIDs carry the same warning about gastrointestinal risk, giving the impression that none is more dangerous than the rest. This is counter to the EMEA finding that prompted the new warning for people in the 27 EU member states that “piroxicam was singled out for special review because piroxicam-containing medicines are associated with more gastro intestinal side effects and more serious skin reactions than other non-selective NSAIDs.”

But due to much negative publicity for this drug, generated by the large number of studies concerning gastrointestinal toxicity published in medical journals and increasing awareness by physicians of these dangers, use of piroxicam decreased in the U.S. There were eight million prescriptions filled in 1984, but the number dropped to 5.5 million in 1992 and continued to decrease to fewer than one million prescriptions in 2002. For reasons that may have to do with doctors (and patients) forgetting how uniquely dangerous this drug is, there has been a recent rebound in the use of piroxicam in the U.S. with more than two million prescriptions filled in 2006, more than a doubling since 2002.

What You Can Do  
If you are currently using piroxicam or your doctor recommends it, discuss with your doctor the use of one of the NSAIDs that is less dangerous to the gastrointestinal tract, such as ibuprofen or naproxen (ALEVE, ANAPROX, NAPROSYN). Naproxen has the added advantage of having the least cardiac risk of the currently-used NSAIDs (both ibuprofen and naproxen are available over the counter).